- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04830072
AR Enhanced Pictorial Warnings on Smoking Cessation
May 19, 2023 updated by: Dr. Wang Man-Ping, The University of Hong Kong
Mobile Phone Based Personalized and Interactive Augmented Reality (AR) Pictures on Enhancing Brief Advice Model for Smoking Cessation: a Pilot Randomized Controlled Trial
This pilot randomized controlled trail aims to test the effects of AR enhanced pictorial effects in harms of smoking and benefit of smoking cessation.
Study Overview
Status
Completed
Conditions
Detailed Description
Conventional health warnings on smoking harms mostly include pictures showing smoking consequences such as lung diseases, peripheral vascular diseases, aging, skin lesions, and benefit of quitting such as improved cardiopulmonary functions, skin conditions and risk of diseases, etc.
The effects of the information are limited by the generic messages, unattractive images, and lack of interaction.
This proposal aims to enhance the "Warn" and "Advice" materials using mobile phone-based augmented reality (AR) technologies to provide personalized, interactive, and attractive images to encourage smokers to quit smoking.
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Hong Kong, Hong Kong
- School of Nursing, The University of Hong Kong
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Hong Kong adults aged 18 or above;
- Smoke at least 1 cigarette daily in the past 30 days;
- Own a smartphone and familiar with instant messaging apps;
- Able to read and communicate in Chinese.
Exclusion Criteria:
- Participate in other smoking cessation services or projects
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: AR group
Brief AWARD advice + active referral + leaflet + 3 months chat-based support with AR pictures
|
The AWARD advice includes: (1) Ask about smoking history; (2) Warn about the high risk of smoking; (3) Advise to quit or reduce smoking as soon as possible; (4) Refer smokers to smoking cessation services (with a referral card); (5) Do it again: to repeat the intervention.
Participants in the intervention group will receive 3 months of chat-based support through Instant Messaging apps (e.g., WhatsApp, WeChat).
The support mainly includes (1) regular messages on health warnings, benefits and methods of quitting, coping craving approach, and promotion to use the SC services; (2) real-time, personalized, and interactive behavioral and psychosocial support through Instant Messaging apps.
Leaflet on harms of smoking
AR images of the harms of smoking and the benefit of abstinence.
|
Active Comparator: Control group
Brief AWARD advice + active referral + leaflet + 3 months chat-based support
|
The AWARD advice includes: (1) Ask about smoking history; (2) Warn about the high risk of smoking; (3) Advise to quit or reduce smoking as soon as possible; (4) Refer smokers to smoking cessation services (with a referral card); (5) Do it again: to repeat the intervention.
Participants in the intervention group will receive 3 months of chat-based support through Instant Messaging apps (e.g., WhatsApp, WeChat).
The support mainly includes (1) regular messages on health warnings, benefits and methods of quitting, coping craving approach, and promotion to use the SC services; (2) real-time, personalized, and interactive behavioral and psychosocial support through Instant Messaging apps.
Leaflet on harms of smoking
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-reported past 7-day point prevalence abstinence
Time Frame: 3 months after baseline
|
Abstain from smoking in the past 7 days
|
3 months after baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-reported past 7-day point prevalence abstinence
Time Frame: 1 months after baseline
|
Abstain from smoking in the past 7 days
|
1 months after baseline
|
Self-reported smoking reduction by at least 50%
Time Frame: 3 months after baseline
|
Defined by at least 50% reduction in baseline daily cigarette consumption
|
3 months after baseline
|
Self-reported smoking reduction by at least 50%
Time Frame: 1 months after baseline
|
Defined by at least 50% reduction in baseline daily cigarette consumption
|
1 months after baseline
|
Self-reported quit attempts
Time Frame: 3 months after baseline
|
Defined by abstinence for at least 24 hours
|
3 months after baseline
|
Self-reported quit attempts
Time Frame: 1 months after baseline
|
Defined by abstinence for at least 24 hours
|
1 months after baseline
|
Recall of pictorial warnings
Time Frame: 3 months after baseline
|
Defined by the recall of the quitline on warning pictures
|
3 months after baseline
|
Recall of pictorial warnings
Time Frame: 1 months after baseline
|
Defined by the recall of the quitline on warning pictures
|
1 months after baseline
|
Attention of pictorial warnings
Time Frame: 1 months after baseline
|
Defined by notice of pictorial warning
|
1 months after baseline
|
Attention of pictorial warnings
Time Frame: 3 months after baseline
|
Defined by notice of pictorial warning
|
3 months after baseline
|
Self-reported intention to quit
Time Frame: 1 months after baseline
|
Defined by readiness to quit in 30 days
|
1 months after baseline
|
Self-reported intention to quit
Time Frame: 3 months after baseline
|
Defined by readiness to quit in 30 days
|
3 months after baseline
|
Reactions to the pictorial warnings
Time Frame: 3 months after baseline
|
Defined by behaviors to avoid seeing pictorial warnings
|
3 months after baseline
|
Reactions to the pictorial warnings
Time Frame: 1 months after baseline
|
Defined by behaviors to avoid seeing pictorial warnings
|
1 months after baseline
|
Perceived effectiveness of AR images
Time Frame: 1 months after baseline
|
Defined by ratings on the effectiveness of AR images to encourage quitting
|
1 months after baseline
|
Perceived effectiveness of AR images
Time Frame: 3 months after baseline
|
Defined by ratings on the effectiveness of AR images to encourage quitting
|
3 months after baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Man Ping Wang, PhD, The University of Hong Kong
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 23, 2021
Primary Completion (Actual)
March 31, 2022
Study Completion (Actual)
June 30, 2022
Study Registration Dates
First Submitted
March 24, 2021
First Submitted That Met QC Criteria
March 31, 2021
First Posted (Actual)
April 2, 2021
Study Record Updates
Last Update Posted (Actual)
May 22, 2023
Last Update Submitted That Met QC Criteria
May 19, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- Pictorial warning AR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Smoking Cessation
-
University of Southern CaliforniaAmerican Cancer Society, Inc.CompletedSmoking | Smoking Cessation | Smoking, Cigarette | Smoking Behaviors | Cessation, SmokingUnited States
-
Nabi BiopharmaceuticalsNational Institute on Drug Abuse (NIDA)CompletedSmoking | Smoking Cessation | Tobacco CessationUnited States
-
Claremont Graduate UniversityNational Cancer Institute (NCI)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, CigaretteUnited States
-
Heidelberg UniversityPfizerTerminatedSmoking | Smoking Cessation | Tobacco Use CessationGermany
-
Mayo ClinicNational Institute on Drug Abuse (NIDA)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, Tobacco | Smoking, CigaretteUnited States
-
University of MiamiFlorida Department of HealthRecruitingSmoking Cessation | Tobacco Smoking | Tobacco Use CessationUnited States
-
University of VermontMayo Clinic; Alaska Native Tribal Health ConsortiumTerminatedSmoking | Smoking CessationUnited States
-
University of Wisconsin, MadisonCentiment LLCCompletedSmoking | Smoking CessationUnited States
-
Yale UniversityCompletedSmoking | Smoking CessationUnited States
-
Johns Hopkins UniversityMaryland Department of Health and Mental HygieneCompletedCOach2Quit TRIAL: Assessing a Prototype Personal Carbon Monoxide Monitor for Smoking Cessation (C2Q)Smoking | Smoking CessationUnited States
Clinical Trials on Brief AWARD advice and active referral to somking cessation services
-
The University of Hong KongHong Kong Council on Smoking and HealthCompleted
-
The University of Hong KongHong Kong Council on Smoking and HealthCompleted
-
The University of Hong KongUnknownSmoking CessationHong Kong
-
The University of Hong KongHong Kong Council on Smoking and HealthNot yet recruiting
-
The University of Hong KongHong Kong Council on Smoking and HealthCompletedSmoking CessationHong Kong
-
The University of Hong KongHong Kong Council on Smoking and HealthCompleted
-
The University of Hong KongHong Kong Council on Smoking and HealthCompleted
-
The University of Hong KongCompleted
-
The University of Hong KongHong Kong Council on Smoking and HealthRecruiting
-
The University of Hong KongHong Kong Council on Smoking and HealthUnknownSmoking CessationHong Kong